Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Gingival Depigmentation by Diode Laser

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02143375
Recruitment Status : Completed
First Posted : May 21, 2014
Last Update Posted : May 21, 2014
Sponsor:
Information provided by (Responsible Party):
Somayyeh Babaei, Shahid Beheshti University of Medical Sciences

Brief Summary:
Physiologic gingival pigmentation(PGP) is the most common type of gingival pigmentation and cosmetic concern particularly in gummy smile patients. Laser therapy is an effective and noninvasive treatment option. The aim of this study was to evaluate the efficacy of diod laser on the treatment of PGP in patients.

Condition or disease Intervention/treatment Phase
Laser-induced Hypopigmentation Device: 810 Diode Laser Phase 1

Detailed Description:

Preoperative and postoperative photographic and clinical observations about the gingival melanin pigmentation were made according to Dummett-Gupta Oral Pigmentation Index scoring criteria given by Dummett C.O. in 1964 The investigators classified pigmented gingiva in patients as:

  1. Mild:Pink to slightly brown
  2. Moderate:Deep brown or black
  3. Severe:Mixed in color Score in each tooth was taken including one full inter dental papilla. Observations were made in natural light. The assessment of the scoring of the pigmentation index were done by all the three examiners, and the agreed upon score was assigned to prevent individual variations.

The investigators compared the intensity of pigmentation in each patient in recall sessions after 1month and 3mounth postoperative.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of810 nm Diode Laser on Gingival Pigmentation
Study Start Date : April 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : March 2014

Arm Intervention/treatment
Experimental: 810 Diode Laser
810 nm Diode Laser, contact, continuous wave,320micron,
Device: 810 Diode Laser
The 810-nm diode laser has energy and wavelength characteristics that specially target the soft tissues. It has an affinity for hemoglobin and melanin, so it is an excellent soft tissue laser and is applicated for cutting and coagulating gingival tissue.Today,sparse studies have been published assessing physiologic gingival pigmentation using diode laser,therefore the aim of this study was to evaluate the effect of diode laser on the treatment of gingival pigmentation in adult patients.




Primary Outcome Measures :
  1. improvement of gingival pigmentation [ Time Frame: 1 month ]
    standard digital photographs were taken preoperative,1 month after laser therapy.


Secondary Outcome Measures :
  1. changes in pigmentation based on standard digital photographs and index of Dummett et al. [ Time Frame: 3month ]
    standard digital photographs were taken 3 months postoperative.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 19 adult patients who had been referred to oral medicine department of Shahid Beheshti dental school with the chief complaint of melanin pigmentation were selected for inclusion in this study.

Exclusion Criteria:

  1. Hyperpigmentation that was associated with systemic disease or drug administration,disease that could compromise wound healing (uncontrolled diabetes, autoimmune disease)
  2. Pregnancy or lactation
  3. Evidence of relationship between hyperpigmentation and malignancy
  4. History of previous treatment of hyperpigmentation
  5. Smoking
  6. Periodontal problems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143375


Locations
Layout table for location information
Iran, Islamic Republic of
Shahid Beheshti medical university,Dental Faculty
Tehran, Iran, Islamic Republic of, +98
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
Layout table for investigator information
Study Chair: Mahin Bakhshi, DDS.MS Associate Professor of Oral Medicine Department ,Shahid Beheshti Medical University
Layout table for additonal information
Responsible Party: Somayyeh Babaei, Dr, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02143375    
Other Study ID Numbers: mbakhshi
First Posted: May 21, 2014    Key Record Dates
Last Update Posted: May 21, 2014
Last Verified: April 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypopigmentation
Pigmentation Disorders
Skin Diseases